Now that a company name has surfaced we can put the pieces together back to 2007 when Rosacea News featured a publication that suggested that a viable alternative to Sansrosa was about to compete in the anti-redness race. The author of that paper, Dr. D. Shanler is a holder of multiple patents relating to alpha adrenoceptor agonists and treating skin conditions.

While it can’t be said for sure that V-101 is oxymetazoline, it is encouraging to see a product of this sort slowly making its way through the drug development cycle.

V-101 was found to offer a benefit to the redness of rosacea, and was not detectable in the blood of users.

Vicept Therapeutics Announces Positive Clinical Study Results of V-101 for the Treatment of the Erythema of Rosacea

MALVERN, Pa., Aug. 5 /PRNewswire/ — Vicept Therapeutics, Inc., a privately held specialty biopharmaceutical company, announced positive results today from a pharmacodynamic and pharmacokinetic clinical trial of the Company’s lead product V-101, a topical cream under investigation for the treatment of erythema in patients with rosacea.

The double-blinded, placebo-controlled, crossover clinical trial of 22 patients with rosacea was designed to evaluate the bioavailability of V-101 and provide preliminary evidence of efficacy as measured by improvement in moderate to severe erythema, the bright redness of the skin associated with rosacea.  V-101 had a side effect profile similar to placebo and V-101′s active ingredient was not detectable in study participants’ plasma, a strong indication of the product’s overall tolerability and safety profile.  Additionally, the study results were positive for all endpoints, demonstrating a clinically and statistically significant improvement in treating the erythema associated with rosacea.

“This important study demonstrated that V-101 has a good safety profile and provides statistically significant evidence of effectiveness in treating the erythema of rosacea,” said Dr. Neal Walker, president and chief executive officer of Vicept. “We look forward to advancing our clinical program into Phase II and continuing our efforts to develop this product for the 16 million people in the United States who live with this common, chronic skin condition every day.”

Related Articles

• Vicept Therapeutics gets funding for V-101
• Sansrosa’s sister to enter redness race
• oxymetazoline good for 6 hours and safe for 3 months
• oxymetazoline may be good for 2 years
• AAD Poster Sessions: oxymetazoline
• patents abound for treating rosacea with alpha agonist

Vicept Therapuetics is based in Malvern in Pennsylvania and is a privately held company.

From Fidelity Biosciences Joins $10M Series A for Vicept Therapeutics

“We are delighted by the strong investor interest in this round of financing which will allow us to continue to advance the development of our product pipeline utilizing our novel, patent protected α-adrenergic receptor technology for the treatment of diseases of the skin,” added Dr. Walker. “With this investment, we will have the necessary resources to continue progress with our lead candidate through Phase II for rosacea as well as pursuing other dermatologic conditions including actinic purpura and peri-procedural bruising of the skin.”

Great to see another company getting funding to develop new treatments for rosacea. Obviously there is a belief by venture capitalists that rosacea is a growth market, especially for the treatment for erythema.

The following patent looks likely to be related to the company and their product development.

COMPOSITIONS AND METHODS FOR TREATING PURPURA

(WO/2009/065116)

PCT/US2008/083774

VICEPT THERAPEUTICS, INC

SHANLER, Stuart D; ONDO, Andrew

Embodiments of the present invention are directed to compositions and methods for the treatment of purpura. Preferred compositions comprise an α adrenergic receptor agonist selected from selective α₁ adrenergic receptor agonist, selective α₂ adrenergic receptor agonist, non-selective α₁/α₂adrenergic receptor agonist, agents with α₂ adrenergic receptor agonist activity and combinations thereof, in a pharmaceutically acceptable carrier in order to treat and improve the cosmetic appearance of hemorrhagic (purpuric) lesions in the skin.

The authors of this 2009 patent describe some trials where the following formulations were trialled;

• Oxymetazoline hydrochloride from Afrin Original 12 Hour Nasal Spray
• Naphazoline hydrochloride from Clear Eyes Maximum Redness Relief
• Tetrahydrozoline hydrochloride from Visine Original
• Phenylephrine hydrochloride from Neo-Synephrine Extra Strength Spray
• Brimonidine tartrate from Bausch & Lomb
• Oxymetazoline hydrochloride and brimonidine tartrate combined.

The results of this trial claimed;

… that this demonstrates that selective αi adrenergic receptor agonists and selective α₂ adrenergic receptor agonists, used separately or in combination, when topically applied to and around a treatment site after a procedure that can/will induce purpura, will reduce the size and appearance of the purpuric macules/ patches and is an effective treatment to hasten their resolution.

The source of the purpura in this instance was a pulse dye laser at 585nm.

The publishers of this patent have an additional similar patent that was mentioned by Rosacea News  in 2007;  Sansrosa’s sister to enter redness race

Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using a1-adrenoceptor agonists

United States Patent Application 20050165079

Shanler, Stuart D.; (New York, NY) ; Ondo, Andrew; (Las Cruces, NM)

The present invention is directed to the treatment of skin erythema as exhibited in rosacea and other conditions characterized by increased erythema (redness) of the skin. These conditions exhibit dilation of blood vessels due to a cutaneous vascular hyper-reactivity. In particular, the present invention is directed to a novel composition and method for the treatment of skin erythema using .alpha..sub.1-adrenergic receptor (.alpha..sub.1-adrenoceptor) agonists incorporated into cosmetic, pharmacological or dermatological compositions for topical application to the skin.

Whilst it appears that no new molecules have been discovered, these patents, if allowed, will protect the usage of these formulations to treat the redness of several skin conditions including rosacea. As we have seen with the Sanrosa product it can take many years and a large investment in R&D to progress from a discovery to a sellable product. It is great news that Vicept has secured funding to begin this drug approval process.

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A recent submission to the House of Commons Science and Technology Committee has said that using public money on the highly-diluted remedies of homeopathy could not be justified.

The cross-party group said there was no evidence beyond a placebo effect, when a patient gets better because of their belief that the treatment works.

I was surprised to read that about £4m a year is spent on homeopathy by the NHS, helping to fund four homeopathic hospitals in London, Bristol, Liverpool and Glasgow and also numerous prescriptions.

As homeopathic remedies are often active ingredients diluted to undetectable levels, it is thought that the placebo effect is responsible for any perceived benefits. The MPs say that the NHS should not be funding these treatments on this basis.

How did we get here ?

How is it possible that an organisation like the the NHS who needs every cent to run a health service for all of Britain could be funding unproven therapies ?

Well the articles answer this question. The use of homeopathics and the belief in their effectiveness predates the NHS legislation. When the act that ushered in when the NHS was penned in 1948, homeopathics were already established in the minds of many Brits.

The MPs contended that the licensing for homeopathic treatments is set too low and the fact that they are tolerated, and even funded by the NHS gives undeserved authority in the minds of consumers.

But People Want Them

Despite the lack of evidence, customers want homeopathic remedies. There seems to be some innate belief in the science of homeopathy. Perhaps this belief is based on the desire for alternative or complementary medicines to exist in some form. The desire for products with no side effects may also be fuelling the desire for this class of products.

Paul Bennett, Superintendent Pharmacist at Boots, suggested in a submission that even though he has no proof that homeopathy works they continue to stock homeopathic products across their stores because there is a strong desire for them from his customers.

Our Own Enemy ?

Is the customer always right ? How about when you are selling something that you know can’t work ? Who protects the customer from themselves ?

NHS money ‘wasted’ on homeopathy

By Nick Triggle, Health reporter, BBC News

The NHS should stop funding homeopathy, MPs say.

The House of Commons Science and Technology Committee said using public money on the highly-diluted remedies could not be justified.

The cross-party group said there was no evidence beyond a placebo effect, when a patient gets better because of their belief that the treatment works.

and also from The Times

NHS should stop funding homeopathy, say MPs

From The Times, February 23, 2010

The NHS should stop funding all homeopathic medicine, the House of Commons science watchdog said yesterday. The cross-party group said there was no evidence that homeopathic remedies had anything other than a placebo effect.

The NHS spends about £4 million a year on homeopathy, paying for prescriptions and supporting the running of four homeopathic hospitals.

Phil Willis, the chairman of the Science and Technology Select Committee, said that government policies on homeopathy were not based on sound evidence: “It sets an unfortunate precedent for the Department of Health to consider that the existence of a community which believes that homeopathy works is ‘evidence’ enough to continue spending public money on it.”

Homeopathy uses highly diluted substances to relieve a range of ailments including bruising, colds and flu, and anxiety. But the MPs said that homeopathic remedies were sugar pills that only worked because patients believed that the treatment was going to make them feel better.

Is this the right move ?

Do you think that complementary or alternative treatments like homeopathy should be held to the same standards as regular prescription items ? Should homeopathy receive public funding ?

If you have tried a homeopathic remedy and it helped you, or indeed had no effect, please let us know in the comments below.

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The volcanic stuff being spewed into the air is rich in sulphurous materials. Sulphur, of course, is a well established rosacea topical. Now, you may be sure that this is no desperate effort to make that which is topical, relevant: rosaceans have often reported considerable improvement when spending time at the seaside. Sulphurous compounds are especially abundant in the air about the coast. Intriguingly, one of these – dimethyl sulphate – is a precursor to DMSO, a penetration enhancer. (Slap on your Metrogel, Finacea or Elidel and head to the beach!)

The rosacean’s ideal holiday destination? The coast of Iceland during her warm summer months, perhaps?  Just don’t look at the bar bill.

An interesting piece in the Australian media recently looking at whether treating patients knowingly with placebo treatments might actually offer some benefits.

I have always been fascinated with the whole placebo effect. How exactly can our belief in a treatment affect the outcome of that treatment ? The effect speaks to the whole mind <-> body link in a way that we can measure.

We know that the placebo effect is real. All successful clinical trials need to show that their active ingredient outperforms the baseline of a placebo treatment.

According to researchers quoted, it is not the sugar pill or fake injection that offers a benefit, but the “act of treatment switches on the brain to heal”.

What about a placebo treatment as the main treatment ? Crazy stuff. It might just work in some instances. Professor Michael Cousins says that placebos have very few adverse effects, speaking of them as if they are tangible treatment alternatives.

So, You Wanna buy some expensive fancy looking mumbo jumbo pills, lets call them RosaPlacebo (TM), to treat your rosacea? Only $49.95 a month. Send me your cash now. OK this paragraph is a joke, but you get my point right ? For any untested product, sugar pills are likely just as good.

The corollary is that only products that have proven double blind, placebo controlled, multi-centre results are worth your money. Don’t believe that a treatment works until you see proof that reaches past placebo efficacy.

The article ends with the usual preliminary research disclaimer that more study is needed before placebo treatments can be routinely used.

Placebos activate brain’s ‘heal switch’

Can the act of simply taking a pill make you feel better, regardless of what’s in it?

That’s the idea behind the placebo effect.

The concept has been studied since the end of World War II, when randomised control trials were first introduced.

Researchers found that people given a placebo improved, sometimes dramatically.

…

The new research shows that the placebo effect works, even if patients know they are getting a fake treatment.

The authors use the example of a trial, where a drug was far less effective if patients didn’t know they were getting the medication.

Pain expert Professor Michael Cousins believes placebos will play an important role in treating conditions such as chronic pain.

Another similar article just published in Forbes is also worth a read;

The Nothing Cure

Matthew Herper and Robert Langreth, 03.29.10, 12:00 AM ET

Though recurring tummy aches from irritable bowel syndrome are among patients’ most common complaints, drugmakers have had trouble coming up with a safe and effective treatment. But in 2008 Harvard’s Ted J. Kaptchuk devised a safe remedy that helps far more people than any designer drug ever did.

His magic cure: fake acupuncture delivered with lots of warm talk from a sympathetic acupuncturist–but no needles. In a trial of 262 patients with severe IBS, 62% of those who received the fake treatment got better, according to results published in the British Medical Journal. By comparison, only 28% of a control group of patients put on a waiting list saw their symptoms improve markedly. A third group who got the fake acupuncture, but without any warm talk, showed in-between results: 44% improved

The result, says Kaptchuk, shows just how much the expectation of a cure–and the rituals associated with medical treatment–can improve real-world symptoms. "Our own will, imagination and belief can modulate the course of illness," says Kaptchuk

….

A placebo, he says, is the sum total of all the psychological benefits patients get from seeing their doctors and taking their pills. One theme of his research is that the bigger and more complicated the ritual, the greater the placebo effect. Surgery and medical devices often produce a bigger placebo effect than a pill because expectations for a cure are higher, he says. In a British Medical Journal article in 2006, for example, Kaptchuk and his colleagues reported treating 270 people suffering severe arm pain from repetitive-use injuries with either a placebo pill or fake acupuncture. The people who got the fake acupuncture reported significantly greater reductions in self-reported pain, even though there was no difference in posttreatment grip strength between the groups.

…

It could take decades for researchers like Kaptchuk and Wager to parse all the psychological and neurobiological mechanisms behind the placebo effect. They may never come up with a clear answer as to what is going on. Meanwhile, the next time your doctor recommends an expensive drug or complicated operation to relieve everyday symptoms, it may pay to ask him a simple question. Will the treatment beat a placebo?

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A press release via Reuters details a new and exciting alternative to skin grafts for burn victims. The method includes some stem cells which allows hair follicles and sebaceous glands to develop in the new layers of skin.

This development offers another possible avenue for rosacea treatments similar to Microskin. Of course rosacea is not the same thing as a serious burn but it is exciting to think about how future highly targeted treatments like this will emerge.

The technology is not yet approved for testing on humans.

Skin Cell Spraying Bio Printer Can Heal Burn Victims in Three Weeks

This new bio-printer sprays skin cells on burn victim’s wounds, promoting healthy recovery. The printer is mounted onto a frame that is wheeled over a patient’s hospital bed. A laser reads the depth and shape of the wound, and with the help of a computer the device sprays a precise layer of skin cells that can heal infection-prone wounds in just three weeks.

The skin-spraying project is being developed by scientists and students at Wake Forest University in North Carolina. They are planning to team up with U.S. Armed Forces Institute of Regenerative Medicine to use the device to help wounded soldiers returning from overseas. The process starts as skin cells are separated and purified. They are then placed in a nutritious solution that helps the cells multiply. They are then loaded into the device, sprayed on the skin in layers and voila! Burns are healed. So far they’ve only tested the process on mice, and they were able to successfully heal burns after just three weeks.

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• Microskin now available in the US

You see, James Maki who last year received a partial face transplant reports that, in spite of now being permanently red faced on account of the donor being a rosacean, he is very pleased with the outcome.

How astonishing and how very intriguing. Questions, questions, questions!

If, as is assumed by many, rosacea is evidence of some internal derangement – in the gut perhaps – or some profound irregularity in the body, might we expect Mr. Maki’s rosacea to improve?

If his rosacea does improve is this firm evidence that – in the absence of the disease engine to drive symptom proliferation – broken blood vessels can heal, that unwanted vessels will vanish without the intervention of ablative laser and light treatments?

If his rosacea stays the same, or gets worse, does this indicate that the disease is, after all, quite superficial, and that the symptoms and cause are both to be found about the layers of the skin: its nerves, tiny vessels and structural elements?

However, we should perhaps resist the urge to look upon Mr. Maki as a resource for science, as a guinea pig.  And, while the number of rosacea sufferers is reported to have risen in the United States these last few years, it is unbearably poignant to reflect that Mr. Maki’s recent diagnosis will not have contributed to that rise

Face Transplant Recipient: ‘How Can I Be Disappointed?’

James Maki Discusses Highs & Lows Of Recovery

BOSTON — The Massachusetts man who received partial face transplant at Brigham and Women’s Hospital one year ago is recovering better than he and his doctors had hoped.

James Maki, 60, became only the second American to receive a face transplant during a 17-hour operation on April 8-9, 2009.

…

From 2005 until his transplant in 2009 Maki lived with a severely disfigured face, the result of a fall onto an electrified subway rail. He lost his nose, cheeks, palate and upper lip.

Then in April 2009 Joseph Helfgot, a local father and husband, passed away after heart transplant surgery. His widow, Susan Whitman-Helfgot, knew that organ donation was the right decision.

Weeks after the operation, Maki, his doctors and Whitman-Helfgot held a news conference at which Maki told the world, “I will forever be grateful."

“I got Joseph’s nose, and the rest of it, all this,” Maki told Brunner this month as he gestured to his cheeks. “He had rosacea, which I now have.”

Maki is able to smell with his new nose. He’s also able to taste. “I think everything is close to working right or working alright,” he said.

April 2010. Chicago. A young woman sits at her desk. Spring sunshine streams in through the window.  Her co-workers are complaining of being cold. It is 76 degrees. The report needs to be finished today.  Her job depends on it yet her mind is elsewhere: difficult to concentrate with a swelling, comically red face and pulsating pain.

October 1496.  The court of the Duke of Savoy. A gentlewoman falls to the feet of the physician Biarus and offers him all her worldly possessions  to be rid of her erythematotelangiectatic rosacea. Poor, poor woman.

April 2010. Edinburgh. A divorced, lonely, forty-something male scans the internet dating sites. He has no intention of initiating any contact just now: his rosacea is playing up. He has a face full of pustules but resolves to contact some of the lovely wee lasses when his face is better. His rosacea has been playing up for eight years.

May 1910. New York. JP Morgan is barely refrained from striking a photographer. He has rosacea: a bulbous nose, the full works. Morgan is the richest man on earth, has the self-assurance of ten men, and yet he still feels that way about having his photo taken.

Behind the statistics, there are stories and there is suffering. While the figures are perhaps debatable, and certainly depressing, they offer some crumbs of consolation. The greater and the wider the suffering, the greater becomes the pressure for things to be done about it. Or, if you are feeling especially contemplative this Easter, one might reflect that if everybody suffers, nobody suffers.

What it means

This list suggests that acne is around 10 times more popular than rosacea as a search topic. Also psoriasis, eczema and dermatitis are all searched for more often than rosacea.

Do you find rosacea’s ranking in this list surprising ?

If you would like to volunteer, please send an email to jenna.wilcox@googlemail.com with a little rundown of your treatment history and phone number.